MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	71174934
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during an internal fixation, when the surgeon attempted to drill the 2.0/2.7mm double-ended drill guide with a 2.7 drill, it became jammed in the guide and the guide tube separated from the handle.The drill could not be extracted from the guide.The surgery was completed, without any delay, using a s+n back-up device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Correction: h11.H11: additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the instrument did not break off in the patient, nor did any part fall into the patient.While setting up, the technician pulled on the guide, and it broke when trying to screw it back on.It was discovered that the tip was already broken and was still screwed to the end.It was set aside, a second set of instruments was taken, and the procedure continued.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event as the device damage occurred during preparation activities performed external to the patient and did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.If additional details confirm the occurrence of a reportable event, we will update our records accordingly and submit a subsequent report detailing both the event and our completed investigations.Internal complaint reference: (b)(4).

• Brand Name: 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22837911
• Report Number: 1020279-2025-01411
• Device Sequence Number: 18453423
• Product Code: FZX
• UDI-Device Identifier: 00885556387993
• UDI-Public: 885556387993
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71174934
• Device Lot Number: 22KTD0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown